NCT06797518

Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN

A Multicenter, Single Arm, Open Label Biopsy Study to Evaluate Structural and Functional Changes in Kidneys of Adult Patients With IgA Nephropathy Receiving Iptacopan on Top of Supportive Care

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

A study to investigate the impact of iptacopan treatment on the underlying immunopathology in patients with IgAN by assessing changes in key clinical and molecular markers from baseline to 9 months. The study aims to provide insights into the treatment's systemic and kidney-specific aspects by quantifying the change in mesangial C3c containing fragments deposition, as an indicator of complement activation, and evaluating a variety of biomarkers related to kidney function, damage, and disease progression, including but not limited to Oxford MEST-C score.

Detailed description

The study comprises of a screening period followed by a baseline visit, at which a baseline kidney biopsy will be performed. Eligible participants included in the study will receive iptacopan 200 mg b.i.d for a 9-month treatment period. Dose adjustment of iptacopan is not allowed during the treatment period. At Month 9, upon completion of the treatment period, a follow up biopsy is performed for all participants at the time of end of study (EOS).

Conditions

• Glomerulonephritis, IGA
• Immunoglobulin A Nephropathy

Interventions

Type	Name	Description
DRUG	Iptacopan	LNP023 oral capsule 200 mg b.i.d

Timeline

• Start date: 2025-02-21
• Primary completion: 2027-11-27
• Completion: 2027-11-27
• First posted: 2025-01-28
• Last updated: 2026-03-24

Locations

16 sites across 4 countries: United States, Argentina, Israel, Malaysia

Regulatory

• FDA-regulated drug study